Approaches to Safety Evaluation of Baby Wipes

Abstract

Disposable baby wipes manufactured by Procter & Gamble, soft sheets bearing lotion that is balanced to maintain natural skin pH, are convenient for cleaning the diaper area and a quick cleanup on baby’s face and hands. Objective: Develop a rigorous safety assessment process to ensure that baby wipes are safe and gentle to skin. This process is built-in from the start of product research and development. Methods: A systematic, iterative approach that includes (1) exposure-based safety assessment of all raw materials for systemic and local effects, which are consistent with established risk assessment paradigms; (2) when needed, testing of finished wipes in in vitro and/or clinical studies for skin and eye irritation, contact sensitization, or mechanical effects on skin in comparison to benchmark products that have a long history of wipe safety in marketplace; (3) prospective and randomized in-use studies in babies; and (4) in-market monitoring that is an integral part of the on-going product safety assessment. Results: Individual approaches and/or their combination show mildness of the test wipes. Further, in-market monitoring is testimony to baby skin compatibility of baby wipes. Conclusion: The approaches that have been developed demonstrate the skin compatibility and/or benefits of baby wipes relative to other modes of cleaning if needed. This article describes our safety assurance program, exposure-based safety assessment, and the range of robust testing strategies and approaches that can be employed to assure the safety of baby wipes.